Dexmedetomidine Sedation and Cardiopulmonary Bypass

NCT ID: NCT02727621

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-09-30

Brief Summary

Dexmedetomidine is a unique sedative anesthetic agent that allows accurate control of the depth of sedation and provides analgesia, cardio protection, renal protection, and neuroprotection without causing respiratory depression. It is an alpha 2-adrenoreceptor agonist that modulates the release of catecholamines from the central and autonomic nervous systems. When patients sedated by dexmedetomidine are allowed to become responsive, they are calm and cooperative (1). No other sedative agent has this feature, and sedated patients frequently awaken in a confused state. Investigators are conducting this study project to compare between dexmedetomidine based and propofol based anesthetic techniques with regard to hemodynamic changes, stress hormone release as well as cytokines in patients undergoing CPB for coronary revascularization.

Detailed Description

100 patients undergoing elective CPB for coronary revascularization surgery. On the morning of operation the patients were randomized to receive one of two anesthetic techniques dependent on the type of sedation used. Standard anesthetic technique will be used for all patients except for using dexmedetomidine sedation in one group and propofol sedation in the other group.

Conditions

Coronary Artery Bypass Grafting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine group

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

Anesthesia will be maintained with continuous infusion of dexmedetomidine 0.5-0.7 µg/kg/h in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values. Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.

Propofol group

Group Type: ACTIVE_COMPARATOR

propofol

Intervention Type: DRUG

Anesthesia will be maintained with continuous infusion of propofol 50-100 µg/kg/min in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values. Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.

Interventions

Dexmedetomidine

Anesthesia will be maintained with continuous infusion of dexmedetomidine 0.5-0.7 µg/kg/h in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values. Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.

Intervention Type: DRUG

propofol

Anesthesia will be maintained with continuous infusion of propofol 50-100 µg/kg/min in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values. Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.

Intervention Type: DRUG

Other Intervention Names

precedex; diprivan

Eligibility Criteria

Inclusion Criteria

• patients scheduled for elective coronary revascularization surgery with cardiopulmonary bypass

Exclusion Criteria

• Severely impaired left ventricular function (ejection fraction <40%)
• Valvular heart disease
• Low cardiac output syndrome
• Uncontrolled rapid atrial fibrillation
• On plavix less than one week
• Severe systemic non-cardiac disease
• Infectious disease
• Poorly controlled diabetes mellitus
• patients on corticosteroids or other immunosuppressive treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sayed Kaoud Abd-Elshafy

Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sayed Abd-Elshafy, MD

Role: PRINCIPAL_INVESTIGATOR

Associate professor, anesthesia and critical care

Locations

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Other Identifiers

IRB000087801

Identifier Type: -

Identifier Source: org_study_id